NovoThirteen® 2500 IU catridecacog (rys) Recombinant coagulation factor XIII Consumer Medicine Information

What is in this leaflet initial blood clot by producing a • are using other blood clotting mesh around the clot. factors. It is not recommended to use NovoThirteen® and ® Ask your doctor or healthcare What NovoThirteen is used for 1 professional if you have any recombinant factor VIIa (another blood clotting factor) Before you use NovoThirteen® . 1 questions about why NovoThirteen® has been given to together; Using NovoThirteen® ...... 2 you. Your doctor may have • are pregnant or trying to become prescribed it for another reason. pregnant; ® While you are using NovoThirteen • are breast-feeding or planning to ...... 2 breast-feed. Before you use Tell your doctor if you have or Side effects ...... 3 ® NovoThirteen have had any medical conditions, Storage ...... 3 especially the following: When NovoThirteen® • blood clots (thrombosis); Product Description ...... 3 should not be used • liver disease or liver damage You should not use or be treated ® Contact your doctor immediately: NovoThirteen User Instructions 4 with NovoThirteen® if you have an allergy to: • If you experience unexpected This leaflet answers some common bleeding during your treatment • catridecacog or any of the ® questions about NovoThirteen®. It does with NovoThirteen . Your ingredients listed at the end of not contain all the available information. doctor will prescribe an this leaflet It does not take the place of talking to alternative treatment to treat the your doctor or healthcare professional. (refer to the section “Side effects” bleeding. to look for signs of an allergic Antibodies with neutralising effect All medicines have risks and benefits. reaction). against NovoThirteen® could Your doctor has weighed the risks of ® decrease the effectiveness of the you using NovoThirteen against the If you are uncertain as to whether treatment and thereby result in benefits they expect it will have for you. you have such an allergy, raise this concern with your doctor. unexpected spontaneous bleeding If you have any concerns about using episodes. Neutralising antibodies this medicine, ask your doctor or Do not use it after the expiry date have not been seen in clinical trials healthcare professional. (‘Expiry’) printed on the carton with NovoThirteen®. and label. Keep this leaflet with the medicine. ® Tell your doctor if you plan to You may need to read it again. Do not use NovoThirteen if the have surgery. packaging is torn, shows signs of tampering or does not look quite If you have not told your doctor/s ® What NovoThirteen is right. about any of the above, tell him/them before you use used for NovoThirteen®. Before you start to use it NovoThirteen® contains the active Tell your doctor if you: substance catridecacog, which is Taking other medicines identical to human coagulation factor • have, or have ever had, a Do not use NovoThirteen® and XIII, and is produced by recombinant higher risk of blood clots blood clotting factor concentrates technology. FXIII is an enzyme forming (thrombosis), as at the same time. necessary for blood clotting. NovoThirteen may increase the Tell your doctor before you use ® severity of a pre-existing blood NovoThirteen® and medicines NovoThirteen is used to prevent clot; bleeding in patients who are missing the used to reduce the dissolving of • factor XIII (A-subunit) protein. are allergic to rFXIII, yeast blood clots. ® protein or to any of the NovoThirteen replaces the missing ® Tell your doctor if you are taking Factor XIII and helps to stabilise the ingredients in NovoThirteen ; any other medicines, including any

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that you buy without a prescription When and how much to How long to use it from your pharmacy, supermarket or use ® health food shop. Do not stop using NovoThirteen NovoThirteen® is given as an without consulting your doctor. injection into a vein. Your dose will Your doctor will explain what might Immediately before you use it depend on your body weight. The happen if you stop treatment and Make sure that: usual dose is 35 IU for each discuss other options with you. kilogram of body weight. The • the packaging is not damaged or injections are given once a month If you use too much torn; (every 28 +/- 2 days). (overdose) • the protective tamper-proof plastic Based on the concentration of ® If you are given or if you give caps are in place, and are not loose NovoThirteen solution, the dose ® yourself too much NovoThirteen or missing; volume to be injected (in millilitres) you should contact your doctor ® can be calculated from this formula: • the NovoThirteen powder in the immediately. Your doctor will take vial is white and the solvent is a Dose volume in millilitres = 0.042 x appropriate action. clear colourless solution; your body weight in kg. If you have any concerns about • the vials are not damaged Use in small children taking this medicine, ask your If you need to give NovoThirteen® doctor or haemophilia nurse. ® to a child weighing less than 24 kg Using NovoThirteen you should dilute the reconstituted If you forget to use it ® ® NovoThirteen with 6.0 mL of You should contact your doctor who How to use NovoThirteen sodium chloride 0.9% solution for ® will take the appropriate action. Do Start of treatment with NovoThirteen injection. This makes the dosing of not take a double dose to make up should be supervised by a doctor with small children easier. For more for a forgotten dose. experience in rare bleeding conditions. information see section ‘Dilution of Following treatment cycles should also the reconstituted product with be supervised by a doctor for a period of sodium chloride 0.9% solution for While you are using time. Always use this medicine exactly injection’ in the NovoThirteen® ® as your doctor has told you. Check with user instruction. NovoThirteen your doctor or healthcare professional if The dose volume for the use in you are not sure. Things you must do small children can be calculated NovoThirteen® is given as an injection from this formula You and your doctor should monitor into a vein. Solvent must be added your bleeding. Tell your doctor or Dose volume in mL = 0.117 x body (reconstitution) to the vial of nurse if your bleeding gets worse. weight in kilograms. NovoThirteen® powder before the solution is injected. The solution should Your doctor may adapt the dose if Contact your doctor be clear and colourless. this is deemed necessary. immediately: ® Reconstitution and injection: The reconstituted NovoThirteen • If you experience unexpected should be administered as a slow Please refer to the user instructions. bleeding during your treatment bolus intravenous injection at a rate ® ® with NovoThirteen . Your NovoThirteen is for single use in one not higher than 2 mL/minute. doctor may prescribe an person only. Once NovoThirteen® has For more information on how to get alternative treatment to treat the been prepared for injection, it should be bleeding. used immediately. Discard your vial your injection ready, see ® • after use. ‘NovoThirteen User Instructions’. If you experience unexpected For more information about how to spontaneous bleeding during If the reconstituted product is not used ® treatment with Factor XIII immediately it should be used within 3 inject NovoThirteen contact your doctor containing products. Antibodies hours if stored at temperatures below against NovoThirteen® could 25°C or within 24 hours if stored at 2 - decrease the effectiveness of the 8°C. If it is left longer, the medicine After you use it treatment and thereby result in may no longer be sterile and the amount • Do not refill NovoThirteen® unexpected spontaneous of activated rFXIII will increase. vials. bleeding episodes. Contact Activated rFXIII may increase the risk • Healthcare professionals, your doctor immediately if of getting a blood clot (thrombosis). relatives and other carers bleeding occurs. ® Once NovoThirteen has been should follow general reconstituted it must not be frozen. If the precautionary measures for Things you must not do reconstituted product does freeze it must removal and disposal of Do not give NovoThirteen® to not be used and must be discarded. needles to eliminate the risk of anyone else, even if they have the needle stick injury. same condition as you.

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Do not use NovoThirteen® to treat Ask your doctor or haemophilia Sodium hydroxide and hydrochloric any other complaints. nurse to answer any questions acid are used to adjust the pH. ® you have. Do not stop using NovoThirteen , or The solvent vial contains water for adjust the dosage, without checking injections. After reconstitution, 1 mL with your doctor. Storage of the solution contains 833 IU catridecacog (activated). ® Side effects NovoThirteen must be stored at 2- 8ºC. It should not be frozen. If the Manufacturer product freezes it should be ® All medicines can have side effects. NovoThirteen is made in Denmark discarded. NovoThirteen® must Sometimes they are serious, most of the and supplied in Australia by: only be used if the package is time they are not. You may need undamaged and the use by Novo Nordisk Pharmaceuticals Pty. medical treatment if you get some of the (‘expiry’) date marked on the pack Ltd. side effects. has not passed. Level 3 Tell your doctor or pharmacist if you Protect from light. 21 Solent Circuit notice any of the following and they Baulkham Hills NSW 2153 worry you: ® Never use NovoThirteen after This leaflet was prepared on - headache the expiry date printed on the 19 September 2018. label and carton. - local reaction around the injection site such as redness, itchiness, The expiry date refers to the last Australian Registration Numbers: tenderness, pain or discomfort day of that month. AUST R 201776 ® - pain in the legs or arms Never use NovoThirteen vials if the solution is not clear and NovoThirteen® is a registered - frequent infections, such as fever, colourless when reconstituted trademark of Novo Nordisk severe chills, sore throat or mouth with the solvent. HealthCare AG, Switzerland. ulcers which may be symptoms of a lack of white blood cells Keep out of the reach of children. NovoCare® is a registered trademark The above list includes the more of Novo Nordisk A/S. common side effects of your medicine. Product Description © 2018 Contact your doctor immediately, or Novo Nordisk A/S go to the accident and emergency NovoThirteen® can only be department at your nearest hospital if obtained from a hospital or For further information call the ® you have an allergic reaction. The haemophilia treatment centre. NovoCare Customer Care Centre signs might include: on 1800 668 626 (Australia). This leaflet does not tell you all that - sudden signs of allergy, such as rash, is known about NovoThirteen®. If www.novonordisk.com.au hives or itching, swelling of the face, you have any questions about lips, tongue or other parts of the NovoThirteen®, ask your doctor body or nurse. - pinkish, itchy swellings on the skin What it looks like - shortness of breath, wheezing or NovoThirteen® is supplied as a difficulty breathing white powder, in a glass vial. The - low blood pressure (cold clammy powder must be dissolved with the skin, rapid weak heartbeat) solvent before it is used. - feeling dizzy and sweating Ingredients These are serious side effects and you may need urgent medical attention. The active ingredient in NovoThirteen® is recombinant Your doctor will have more information coagulation factor XIII (rFXIII), about unwanted effects of ® which is also called catridecacog NovoThirteen . (rys). NovoThirteen® is made by Tell your doctor or haemophilia nurse genetic engineering. as soon as possible if you notice any Each vial contains 2500 IU side effects or do not feel well while ® (International Units) (15.0 mg) of you are using NovoThirteen . rFXIII. Each vial also contains Do not be alarmed by this list of sodium chloride, sucrose, possible side effects. You may not polysorbate 20 and L-histidine. experience any of them.

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NovoThirteen® User vial (water for injection). Take care not D to touch the spike on the vial adaptor. Instructions A

E Hold the syringe with the solvent vial upside down. Pull the plunger to draw

B the solvent into the syringe.

Once attached, remove the protective E To reconstitute and administer cap from the vial adaptor by lightly this product the following tools squeezing the protective cap with your are needed: a 10 ml syringe or thumb and index finger as shown. a syringe of convenient size according to the injection volume, alcohol swabs, the B included vial adaptor and an infusion set (tubing, butterfly needle).

Preparing the solution Check the name and the colour of the package to make sure it F contains the right product as Remove the empty solvent vial by well as that the product has not tipping the syringe with the vial passed the expired date. adaptor. Always use an aseptic technique. Before starting, C F wash your hands. Bring the Pull the plunger to draw in a volume powder and solvent vials to a of air that is equal to the amount of room temperature not above solvent in the solvent vial (mL equals 25°C, by holding them in the cc on the syringe). hands until they feel as warn as your hands. Remove the plastic C caps from the two vials. If the caps are loose or missing, do not use the vials. Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use. Do not G touch the rubber stoppers after Click the vial adaptor, still attached to wiping them. the syringe, onto the powder vial. Hold the syringe slightly tilted with the A vial facing downwards. Push the The product is reconstituted plunger slowly to inject the solvent using the vial adaptor included. D into the powder vial. Make sure not to Remove the protective paper Screw the syringe securely onto the aim the stream of solvent directly at from the vial adaptor without vial adaptor on the solvent vial. Inject the powder as this will cause foaming. taking the vial out of the air into the vial by pushing the plunger protective cap. If the protective until you feel a clear resistance. paper is not fully sealed, or if it is broken, do not use the vial adaptor. Place the solvent vial on a flat solid place and attach the vial adaptor to the solvent

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G be stored at room temperature (below J 25°C) during this time. Any unused product stored at room temperature for 3 hours should be discarded. If the reconstituted product is not administered immediately, it should be stored in the refrigerator at 2°C - 8°C for no longer than 24 hours.

The reconstituted product must not be frozen. If the reconstituted product does become frozen it must not be used and must be discarded. K In case a dilution of the reconstituted H ® Safely dispose of the syringe, vial NovoThirteen is needed, proceed to Gently swirl the vial until all adaptor, infusion set and vials. Any the section ‘Dilution of the the powder is dissolved. Do not unused medicinal product or waste reconstituted product with sodium shake the vial as this will cause material should be disposed of in chloride 0.9%, solution for injection’. foaming. accordance with local requirements or

NovoThirteen® should be as instructed by your healthcare Injecting the solution inspected visually for professional. I extraneous (for any foeign) Ensure that the plunger is pushed all particulate matter and the way in before turning the syringe K discolouration prior to upside down (it may have administration. In the event of been pushed out by the pressure in the either beubg observed, discard vial). Hold the syringe with the vial the medicinal product. upside down and pull the plunger to Reconstituted NovoThirteen® is draw up the amount calculated for the a clear, colourless solution. If a injection. larger dose is needed, repeat the procedure in a separate syringe until the required dose I is reached.

H Dilution of the reconstituted product with sodium chloride 0.9% If dilution of the reconstituted NovoThirteen® is necessary in order to be able to handle the dosing of children below 24 kg the reconstituted ® NovoThirteen should be diluted with 6.0 mL 0.9% sodium chloride (see J section ‘Using NovoThirteen® - Use in Unscrew the vial adaptor with the vial. small children’). The product is now ready for injection

in the vein. Follow the injection procedure as instructed by your User instruction on how to dilute the Important Information ® ® healthcare professional. reconstituted NovoThirteen Once prepared, NovoThirteen Following reconstitution the product for injection should be used To dilute the reconstituted should be administered separately and ® immediately. This is because NovoThirteen the following tools are not mixed with infusion solutions nor the medicine may no longer be needed: a vial containing sodiuk be given in a drip. sterile. Also the amount of non- chloride 0.9% solution for injection, a The preparation should be proteolytically activated rFXIII 10 mL syringe, alcohol swabs. administeredI as a slow bolus in the medicine will increase. intravenous injection at a rate not General instruction for dilution Non-proteolytically activated ® higher than 2 mL/minute. NovoThirteen may increase The dilution should be performed in the risk of getting a blood clot accordance with aseptic rules. (thrombosis). Carefully draw 6.0 mL sodium If the reconstituted product is chloride 0.9%, solution for injection, not used immediately it should into the 10 mL syringe. be used within 3 hours and can

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Slowly inject the 6.0 mL sodium chloride 0.9%, solution for injection, into the reconstituted NovoThirteen® vial. Gently swirl to mix the solution. The diluted solution is a clear, colourless solution. Check the injection solution for particulate matter and for discolouration. If either is noticed, please discard. Ask your doctor for advice before the reconstituted NovoThirteen® is diluted with sodium chloride 0.9%, solution for injection.

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